Two Clinical Programs to Treat Underserved Central Nervous System Disorders

THX-110: For the treat­ment of symptoms related to Tourette Syndrome (TS). Several studies show the benefi­cial effects of THC in treat­ment of TS patients.

The THX-110 program takes a unique approach to cannabi­noid formu­la­tion using the “Entourage Effect” (i.e. in which Endocannabinoid system constituents work syner­gis­ti­cally together). THX-110 is a combi­na­tion drug based on dronabinol, an FDA approved synthetic analog of THC, and PEA, PEA is naturally occur­ring in various food sources such as egg yolk, soybeans and milk. In parts of Europe, PEA derived products (e.g., Normast® and Pelvilen®) have been marketed as a food for special medical purposes. In April 2015, Health Canada added PEA to its list of Natural Health Products, a class of health products which includes vitamins, mineral supple­ments, herbal prepa­ra­tions, tradi­tional and homeo­pathic medicines, probi­otics and enzymes.

Therapix is seeking orphan drug desig­na­tion to treat TS.

In a letter dated September 29, 2016, the FDA informed Therapix that its request cannot be granted at this time, and is being held in abeyance until and subject to the company providing the FDA with additional infor­ma­tion pertaining to the overall preva­lence of TS in both children and adults, and further clinical data to support its scien­tific ratio­nale for its request for orphan drug desig­na­tion within 12 months. Therapix intends to respond within the 12 month period, or during any exten­sion thereof.

THX-130: Targeted to the high value and under-served market of mild cogni­tive impair­ment (MCI), using a unique and propri­etary drug devel­op­ment platform: The “Ultra Low-Dose.”

Both programs use a 505 (b)(2) regula­tory strategy based on prior FDA approval of dronabinol. The 505 (b)(2) strategy entails a relatively low scientific-technological risk compared with devel­op­ment of new chemical entities, combined with relatively low devel­op­ment costs and fast time to market.

Therapix is devel­oping unique nasal and sub-lingual delivery and formu­la­tions to optimize efficacy of active cannabi­noid compounds. Nasal and sub-lingual admin­is­tra­tion of THC has been shown to be superior to oral inges­tion.

Approvals for indica­tions such as TS and MCI may lead to appli­ca­tions in several additional thera­peutic indica­tions, including pain manage­ment, cancer care, anti-inflammatory, derma­tology, and psychi­atric disor­ders.